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Metformin Hydrochloride

These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995

Approved
Approval ID

4d89a4ab-6cdd-4c39-92f9-a137fa27a070

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 2, 2021

Manufacturers
FDA

Aphena Pharma Solutions - Tennessee, LLC

DUNS: 128385585

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Metformin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71610-533
Application NumberANDA078321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2021
FDA Product Classification

INGREDIENTS (6)

Copovidone K25-31Inactive
Code: D9C330MD8B
Classification: IACT
carboxymethylcellulose sodium, unspecified formInactive
Code: K679OBS311
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Metformin HydrochlorideActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT

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Metformin Hydrochloride - FDA Drug Approval Details